[Federal Register Volume 88, Number 70 (Wednesday, April 12, 2023)]
[Notices]
[Pages 22045-22049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-07683]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-0918]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection activity associated
with statutory and regulatory food labeling requirements.
DATES: Either electronic or written comments on the collection of
information must be submitted by June 12, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 12, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-0918 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling Regulations.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
[[Page 22046]]
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Food Labeling Requirements
OMB Control Number 0910-0381--Revision
This information collection supports statutory and regulatory
requirements that govern food labeling, and information collection
recommendations discussed in associated Agency guidance. Sections 4, 5,
and 6 of the Fair Packaging and Labeling Act (FPLA) (15 U.S.C. 1453,
1454, and 1455) and sections 201, 301, 402, 403, 409, 411, 701, and 721
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321,
331, 342, 343, 348, 350, 371, and 379e), establish provisions under
which a food product shall be deemed to be misbranded if, among other
things, its label or labeling fails to bear certain required
information concerning the food product, is false or misleading in any
particular, or bears certain types of unauthorized claims. Implementing
regulations are codified in parts 101, 102, 104, and 105 (21 CFR parts
101, 102, 104, and 105). While regulations in part 101 sets forth
general food labeling provisions, requirements pertaining to the common
or usual name for nonstandardized foods; guidelines for nutritional
quality to prescribe the minimum level or range of nutrient composition
appropriate for a given class of food; and requirements for foods for
special dietary use are found in parts 102, 104, and 105, respectively.
The requirements are intended to ensure the safety of food products
produced or sold in the United States and enable consumers to be
knowledgeable about the foods they purchase and include corresponding
information disclosure requirements, along with the reporting and
recordkeeping provisions, subject to enforcement by FDA.
We provide information resources regarding Food Labeling under the
FD&C Act and its amendments on our website at https://www.fda.gov/food/food-labeling-nutrition. Food labeling is required for most prepared
foods, such as breads, cereals, canned and frozen foods, snacks,
desserts, drinks, etc. Nutrition labeling for raw produce (fruits and
vegetables) and fish is voluntary. We refer to these products as
``conventional'' foods. For detailed information on dietary supplement
labeling requirements visit our website at https://www.fda.gov/food/dietary-supplements. Nutrition labeling provides information for use by
consumers in selecting a nutritious diet. Other information enables
consumers to comparison shop. Ingredient information also enables
consumers to avoid substances to which they may be sensitive. Petitions
or other requests submitted to us provide the basis for us to permit
new labeling statements or to grant exemptions from certain labeling
requirements. Recordkeeping requirements ena ble us to monitor the
basis upon which certain label statements are made for food products
and whether those statements are in compliance with the requirements of
the FD&C Act or the FPLA. Requirements include general content and
format for the labeling of food packaging, including nutrition and
ingredient information. Additional regulations provide for specific
nutrient content claims.
The information collection includes Form FDA 3570 entitled, ``Small
Business Nutrition Labeling Exemption Notice,'' for use as applicable
and available for download from our website at https://www.fda.gov/food/labeling-nutrition-guidance-documents-regulatory-information/small-business-nutrition-labeling-exemption-notice-model-form. We have
also developed the following guidance documents to assist respondents
with various aspects of the information collection:
``Guidance for Industry: Notification of a Health Claim or
Nutrient Content Claim Based on an Authoritative Statement of a
Scientific Body'' (June 1998). The guidance document is available from
our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-notification-health-claim-or-nutrient-content-claim-based-authoritative-statement. The guidance
document discusses sections 403(r)(3) and 403(r)(2) (21 U.S.C.
343(r)(3) and (2)) of the FD&C Act and was issued to provide
instruction on the submission of information to FDA during the initial
phase of implementing these new provisions.
``Questions and Answers: Labeling of Dietary Supplements
as Required by the Dietary Supplement and Nonprescription Drug Consumer
Protection Act'' (September 2009). The guidance document is available
from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-questions-and-answers-regarding-labeling-dietary-supplements-required-dietary. The guidance
document communicates content elements and FDA enforcement of labeling
requirements in section 403(y) of the FD&C Act.
``Substantiation for Dietary Supplement Claims Made Under
Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act''
(January 2009). The guidance document is available from our website at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiation-dietary-supplement-claims-made-under-section-403r-6-federal-food. The guidance document discusses
FDA recommendations regarding claims under section 403(r)(6) of the
FD&C Act.
For operational efficiency, we are revising the information
collection to account for burden that may result from activities
associated with the labeling of certain beers, currently approved in
OMB control number 0910-0728. The Tobacco Tax and Trade Bureau is
[[Page 22047]]
responsible for the dissemination and enforcement of regulations with
respect to the labeling of distilled spirits, certain wines, and malt
beverages issued in the Federal Alcohol Administration Act. However,
and as discussed in the guidance document ``Labeling of Certain Beers
Subject to the Labeling Jurisdiction of the Food and Drug
Administration'' (December 2014), certain bottled or otherwise packaged
beers are subject to section 403 of the FD&C Act. The guidance document
is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration and provides recommendations regarding applicable
labeling requirements for products under FDA's jurisdiction.
We are also revising the information collection to include new
requirements applicable to the gluten-free labeling of fermented or
hydrolyzed foods established through rulemaking (RIN 0910-AH00) and
approved in OMB control number 0910-0817.
Description of Respondents: Respondents to this information
collection are manufacturers, packers, and distributors of food
products, as well as certain food retailers, such as supermarkets and
restaurants, subject to statutory and regulatory food labeling
requirements.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR section; activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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101.9(c)(6)(i); dietary fiber... 28 1 28 1 28
101.9(j)(18) and 101.36(h)(2); 10,000 1 10,000 8 80,000
procedure for small business
nutrition labeling exemption
notice using Form FDA 3570.....
101.12(h); petitions to 1 1 1 80 80
establish or amend referenced
amounts customarily consumed
(RACC).........................
101.69; petitions for nutrient 3 1 3 25 75
content claims.................
101.70; petitions for health 5 1 5 80 400
claims.........................
101.108; written proposal for 1 1 1 40 40
requesting temporary exemptions
from certain regulations for
the purpose of conducting food
labeling experiments...........
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Total....................... .............. .............. 10,038 .............. 80,623
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of
21 CFR section; activity Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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101.9(c)(6)(iii); added sugars \2\............ 31,283 1 31,283 1....................................... 31,283
101.9(c)(6)(i); dietary fiber \2\............. 31,283 1 31,283 1....................................... 31,283
101.9(c)(6)(i)(A); \2\ soluble fiber.......... 31,283 1 31,283 1....................................... 31,283
101.9(c)(6)(i)(B); insoluble fiber \2\........ 31,283 1 31,283 1....................................... 31,283
101.9(c)(8); vitamin E \3\.................... 31,283 1 31,283 1....................................... 31,283
101.9(c)(8); folate/folic acid \3\............ 31,283 1 31,283 1....................................... 31,283
New Products.................................. 216 1 216 1....................................... 216
101.12(e); recordkeeping to document the basis 25 1 25 1....................................... 25
for density-adjusted RACC.
101.13(q)(5); recordkeeping to document the 300,000 1.5 450,000 0.75 (45 minutes)....................... 337,500
basis for nutrient content claims.
101.14(d)(2); recordkeeping to document 300,000 1.5 450,000 0.75 (45 minutes)....................... 337,500
nutrition information related to health
claims for food products.
101.22(i)(4); recordkeeping to document 25 1 25 1....................................... 25
supplier certifications for flavors
designated as containing no artificial
flavors.
101.100(d)(2); recordkeeping pertaining to 1,000 1 1,000 1....................................... 1,000
agreements that form the basis for an
exemption from the labeling requirements of
section 403(c), (e), (g)-(i), (k), and (q) of
the FD&C Act.
101.7(t); recordkeeping pertaining to 100 1 100 1....................................... 100
disclosure requirements for food not
accurately labeled for quality of contents.
101.91; Documentation necessary to verify 5,000 56 280,000 0.45 (~27 minutes)...................... 126,000
compliance with gluten free labeling.
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Total..................................... .............. .............. 1,369,064 ........................................ 990,064
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 22048]]
Our estimate reflects the cumulative average burden we attribute to
the reporting and recordkeeping requirements found in the applicable
regulations; individual collection activities may not be evenly
distributed among respondents and/or the corresponding requirements.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
21 CFR section; activity Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures
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101.3, 101.22, parts 102 and 104; statement of 25,000 1.03 25,750 0.5 (30 minutes)....................... 12,875
identity labeling requirements.
101.4, 101.22, 101.100, parts 102, 104 and 25,000 1.03 25,750 1...................................... 25,750
105; ingredient labeling requirements.
101.5; requirement to specify the name and 25,000 1.03 25,750 0.25 (15 minutes)...................... 6,438
place of business of the manufacturer,
packer, or distributor and, if the food
producer is not the manufacturer of the food
product, its connection with the food product.
101.9, 101.13(n), 101.14(d)(3), 101.62, and 25,000 1.03 25,750 4...................................... 103,000
part 104; labeling requirements for
disclosure of nutrition information.
101.9(g)(9) and 101.36(f)(2); alternative 12 1 12 4...................................... 48
means of compliance permitted.
101.10; requirements for nutrition labeling of 300,000 1.5 450,000 0.25 (15 minutes)...................... 112,500
restaurant foods.
101.12(b); RACC for baking powder, baking 29 2.3 67 1...................................... 67
soda, and pectin.
101.12(e); adjustment to the RACC of an 25 1 25 1...................................... 25
aerated food permitted.
101.12(g); requirement to disclose the serving 5,000 1 5,000 1...................................... 5,000
size that is the basis for a claim made for
the product if the serving size on which the
claim is based differs from the RACC.
101.13(d)(1) and 101.67; requirements to 200 1 200 1...................................... 200
disclose nutrition information for any food
product for which a nutrient content claim is
made.
101.13(j)(2) and (k), 101.54, 101.56, 101.60, 5,000 1 5,000 1...................................... 5,000
101.61, and 101.62; additional disclosure
required if the nutrient content claim
compares the level of a nutrient in one food
with the level of the same nutrient in
another food.
101.13(q)(5); requirement that restaurants 300,000 1.5 450,000 0.75 (45 minutes)...................... 337,500
disclose the basis for nutrient content
claims made for their food.
101.14(d)(2); general requirements for 300,000 1.5 450,000 0.75 (45 minutes)...................... 337,500
disclosure of nutrition information related
to health claims for food products.
101.15; requirements pertaining to prominence 160 10 1,600 8...................................... 12,800
of required statements and use of foreign
language.
101.22(i)(4); supplier certifications for 25 1 25 1...................................... 25
flavors designated as containing no
artificial flavors.
101.30 and 102.33; labeling requirements for 1,500 5 7,500 1...................................... 7,500
fruit or vegetable juice beverages.
101.36; nutrition labeling of dietary 300 40 12,000 4.025.................................. 48,300
supplements.
101.42 and 101.45; nutrition labeling of raw 1,000 1 1,000 0.5 (30 minutes)....................... 500
fruits, vegetables, and fish.
101.45(c); databases of nutrient values for 5 4 20 4...................................... 80
raw fruits, vegetables, and fish.
101.79(c)(2)(i)(D); disclosure requirements 1,000 1 1,000 0.25 (15 minutes)...................... 250
for food labels that contain a folate/neural
tube defect health claim.
101.79(c)(2)(iv); disclosure of amount of 100 1 100 0.25 (15 minutes)...................... 25
folate for food labels that contain a folate/
neural tube defect health claim.
101.100(d); disclosure of agreements that form 1,000 1 1,000 1...................................... 1,000
the basis for exemption from the labeling
requirements of section 403(c), (e), (g),
(h), (i), (k), and (q) of the FD&C Act.
101.7 and 101.100(h); disclosure requirements 25,000 1.03 25,750 0.5 (30 minutes)....................... 12,875
for food not accurately labeled for quantity
of contents and for claiming certain labeling
exemptions.
Nutritional labeling for new products......... 500 1 500 2...................................... 1,000
``Labeling of Certain Beers Subject to the 12 1 12 1...................................... 12
Labeling Jurisdiction of the Food and Drug
Administration''.
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Total..................................... .............. ............... .............. ....................................... 1,030,270
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
These estimates reflect our continued experience with the
information collection. We have made nominal adjustments to reflect the
addition of burden associated with gluten and certain bottled or
otherwise packaged beer; petition submissions received since our last
evaluation of the information collection; and informal communications
with industry regarding food product labeling.
Dated: April 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-07683 Filed 4-11-23; 8:45 am]
BILLING CODE 4164-01-P